Medical network - on July 17, 2016, in the case of global direct investment has fallen sharply, absorption of foreign investment grew by 55.8%, our country medicine manufacturing medical devices has increased by 95%, fully prove the global capital of China's economic confidence. So, China's pharmaceutical industry with foreign investment environment is really about? The future development potential? What will be the main investment direction?
The author of the foreign investment policy environment, present situation and the future trends for the industry. This paper extracts the author held in Shanghai on May 17, 2017, the "2017 China and the eu medicine industry development BBS" report on the speech, the BBS by the Chinese chemical pharmaceutical industry association and the European pharmaceutical industry associations (EFPIA) jointly hosted.
A, Chinese medicine market continues to grow rapidly
1. China has become the world's second largest pharmaceutical market
In 2014, represented by China, India, the asia-pacific region to realize the added value of medical market of $224.1 billion, up 12.18% from a year earlier, the global average growth rate of 2.76% over the same period, China has become the world's second largest pharmaceutical market.
2. China's pharmaceutical industry growth rate is still higher than GDP growth
3. The main factor to boost the growth of China's pharmaceutical market
1) accelerated ageing populations
2) the total health expenses continue to grow
Second, the foreign investment policy environment of Chinese medicine industry
On January 17, 2017, the 47th in davos, Switzerland world economic BBS annual meeting, the leaders said that an open, there should be more Chinese imports and foreign direct investment, China hopes that in the process of globalization, more and more people can share, and China on globalization of lift.
In may this year was held in Beijing the first peak BBS "area" of international cooperation, more determined the confidence of foreign investment in China's pharmaceutical industry.
1. To encourage foreign investment pharmaceutical manufacturing directory (revised in 2016)
For the implementation of the CPC central committee and the state council on further expand opening to the deployment, the national development and reform commission, the ministry of commerce jointly with the departments concerned to 2015 the foreign investment industrial guidance catalogue (hereinafter referred to as the "directory") was revised, the formation of encouraging foreign investment pharmaceutical manufacturing directory (revised in 2016), which involves encouraging medical projects in the following table.
2. China (Shanghai) free trade area of drug regulatory reform and innovation
To encourage foreign investment in China's pharmaceutical industry, all issued corresponding encouraging policies, such as Shanghai free trade zone nearly in simplify the approval process is done a lot of reforms.
First, constantly improve the efficiency of administrative examination and approval
At present, the existing 218 get to shorten time limit for examination and approval of the food and drug administration, accounting for 78.7% of the total approval matters. Free trade zone branch can realize administrative examination and approval items have been transferred to the day 44 events.
Second, improve the network information platform, promote the standardization construction of administrative examination and approval
Prepare the food and drug administration for examination and approval on the trade and business handbook "guide", will handle matters required materials at once inform the applicant, promote clean and efficient service oriented government construction.
Make full use of network information platform, the enterprise procedures and materials, related policies, and all of the public network, vigorously improve the transparency of government operations.
In free trade zone administrative examination and approval system embedded in the administrative efficiency of electronic monitoring module, through the system docking and function calls to check the steps, processes, and handle the process of examination and approval of duty personnel, etc., the real-time monitoring, in violation of the program and beyond the time limit, the system automatically alarm, achieve full control of administrative examination and approval.
Third, encourage third party forces to participate in, form a pattern of the food and drug social work.
3. Medical laws and regulations in line with international standards is accelerating
1) on March 11, 2017 CFDA released on the adjustment of imported drug registration management related matters (draft) ", new drugs will be synchronized global market in China.
(1) in China with international multicenter drug clinical trials, cancel the clinical trials should be registered outside the People's Republic of China with medicine or has already entered a stage Ⅱ or Ⅲ clinical trials, vaccine except drugs;
(2) for international multicenter clinical trials in China, after completion of the international multicenter clinical drug trial can be directly put forward listing application for registration of pharmaceuticals,
(3) to apply for the import of chemical drugs and drug treatment with biological products innovation, cancellation shall obtain overseas pharmaceutical manufacturers in producing countries or regions listed licensing requirements.
2) on May 11, 2017, the CFDA issued "about encouraging drug clinical trial management of related medical equipment innovation reform policy no. 53 (2017), and clinical data exchange with each other.
(1) the applicant in the clinical trial data sources outside, meet the requirements of the relevant Chinese medicine medical device registration, after site inspection can be used for filing an application for registration in China;
(2) foreign enterprises in China international multicenter clinical drug trial, complying with the requirements of drug registration related, after completing the international multicenter clinical trial may directly apply for listing;
(3) the applicant drug administration in Europe, America and Japan approed generic bioequivalence test data, to meet the requirements of drug registration in China, after the on-site inspection can be used to declare generic drug registration in China.
Third, foreign investment in Chinese pharmaceutical industry status quo
According to the ministry of commerce research institute, as of January 2015, the cumulative foreign investment more than 4000 Chinese medicine industry project, the contract amount more than $15 billion.
As of February 2016, RDPAC (China association of enterprises with foreign investment in drug research and development industry committee member companies have set up 49 factories in China, 31 r&d center, the time has r&d about RMB 8 billion. Over the past five years, RDPAC member is introduced to the Chinese market at least 67 species of innovative drugs, accounted for 80% of the Chinese market all listed innovation drugs at the same period. During the 11th five-year plan (2006-2010), with a total investment of 20 billion yuan.
According to the ministry of commerce statistics, in 2016, in the case of global direct investment has fallen sharply, absorption of foreign investment grew by 55.8%, our country medicine manufacturing medical devices has increased by 95%, fully prove the global capital of China's economic confidence.
1. The speed of foreign investment in Chinese pharmaceutical industry continue to grow
From 2008 to 2015, the amount of foreign pharmaceutical enterprises in China's direct investment from overall upward trend is obvious.
2. Project amount increasing of foreign investment of Chinese medicine industry
Foreign investment in China's investment scale is more and more big, the average each project according to the ministry of commerce data, July 1, 2016, foreign direct investment in the pharmaceutical industry, a total of 45 project, the amount of $1.237 billion.
3. The source distribution of foreign investment in Chinese pharmaceutical industry
Investment source of foreign investment of Chinese medicine industry is still a technology more advanced countries like the us and Europe and Japan.
4. The target region distribution of foreign investment of Chinese medicine industry
Foreign investment in China's pharmaceutical projects are mainly distributed in Shanghai, Beijing, jiangsu, guangdong and other developed areas.
Fourth, foreign investment in Chinese pharmaceutical industry trends
1. The four step strategy multinational drug companies to enter China
The pharmaceutical industry as one of the earliest introduction of foreign investment in the field, multinational drug companies to invest in China roughly experienced four steps are as follows:
2. Direct foreign mergers and acquisitions in China high quality domestic medicine companies
3. Multinational drug companies to accelerate the research and development localization in China
4. Transfer part of the product distribution rights to domestic drug firms and to speed up the medical market coverage in China
(the author Dr Zi-ran zhang invited, vice President of Chinese medicine pharmaceutical industry association, and director of medical policies and regulations of) |
